Bildyos is a medicine used to treat the following conditions: - osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and in men who have an increased risk of fractures (broken bones). In women who have been through the menopause, Bildyos reduces the risk of fractures in the spine and elsewhere in the body, including the hips; - bone loss in men receiving treatment for prostate cancer that increases their risk of fractures. Bildyos reduces the risk of fractures in the spine; - bone loss in adults at increased risk of fractures who are treated long term with corticosteroid medicines given by mouth or injection. Bildyos contains the active substance denosumab and is a biological medicine. It is a ‘biosimilar medicine’; this means that Bildyos is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Bildyos is Prolia. For more information on biosimilar medicines, see [here](https://www.ema.europa.eu/en/human-regulatory/overview/biosimilar-medicines).
Therapeutic Indication
### Therapeutic indication Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women, denosumab significantly reduces the risk of vertebral, non-vertebral and hip fractures. Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. In men with prostate cancer receiving hormone ablation, denosumab significantly reduces the risk of vertebral fractures. Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.
Therapeutic Area (MeSH)
ATC Code
M05BX04
ATC Item
denosumab
Pharmacotherapeutic Group
N/A
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| denosumab | N/A | 地舒单抗 |
EMA Name
Bildyos
Medicine Name
Bildyos
Aliases
N/ANo risk management plan link.
